Hi-Torque Whisper View Guide Wire
FDA 510(k) K061453 · Guidant Corp.
510(k) numberK061453
Submission
- Device name
- Hi-Torque Whisper View Guide Wire
- Applicant
- Guidant Corp.
St Paul, MN, US - Received
- May 25, 2006
- Decision date
- June 22, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQX – Wire, Guide, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1330
- Specialty
- Cardiovascular
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Questions and answers
When was Hi-Torque Whisper View Guide Wire cleared by the FDA?
Hi-Torque Whisper View Guide Wire (K061453) received a 510(k) decision of Substantially Equivalent on June 22, 2006, 28 days after the submission was received.
What is the product code of K061453?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.